A Phase I Pharmacokinetic Study of Intraperitoneal CTEP-Supplied Agent Bortezomib (PS-341, NSC 681239, IND# 58443) and Carboplatin (NSC# 241240)in Patients with Persistent or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Principal Investigator
Don Dizon, MD
Status
Terminated
Date Opened To Accrual
April 05 2010
Date Closed to Accrual
July 12 2014
Date of Study Termination
January 27 2018
Disease Site
Gynecologic [GY]
Ovarian
Phase
I
Developmental Therapeutics
No
Primary Objective
To determine the maximum tolerated dose (MTD) and dose-limiting
toxicities of intraperitoneal (IP) bortezomib (BTZ) when administered
with intraperitoneal carboplatin in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent or recurrent and who have failed primary therapy and at least one second-line therapy.
To examine the safety of administering BTZ in combination with carboplatin by the IP route.
Patient Population
Women with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent or recurrent
and who have failed primary therapy and at least one second-line therapy.
Target Accrual
36
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.